MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® TEMPERATURE SENSING FOLEY CATHETER

Catalog Number	119416M
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that once inserted the foley catheter failed to drain the bladder.Bladder scan confirmed urine present and they removed the catheter and found the product to be defective.They were unable to flush water through the lumen of the catheter.Per additional information received via email on 08apr2024, it was reported that the customer had another foley catheter that did not work in cardiovascular operating room (cvor) and needed to be replaced intraoperatively that day.In each event, the temperature sensing foley catheter was inserted into the bladder successfully.Neither of these foley catheters produced urine return.Bladder scans post insertion confirmed urine present in the bladder.The foleys were removed in each event.They planned to look at the lot number of the affected product and pulled all foley kits with same lot number from inventory to be safe.They were very concerned that they might have other affected product throughout the hospital that was placing their patient at risk.This was now a patient safety issue and would like some kind of follow up from bd along with credit for all the kits that they were removing from inventory.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that once inserted the foley catheter failed to drain the bladder.Bladder scan confirmed urine present, and they removed the catheter and found the product to be defective.They were unable to flush water through the lumen of the catheter.Per additional information received via email on 08apr2024, it was reported that the customer had another foley catheter that did not work in cardiovascular operating room (cvor) and needed to be replaced intraoperatively that day.In each event, the temperature sensing foley catheter was inserted into the bladder successfully.Neither of these foley catheters produced urine return.Bladder scans post insertion confirmed urine present in the bladder.The foleys were removed in each event.They planned to look at the lot number of the affected product and pulled all foley kits with same lot number from inventory to be safe.They were very concerned that they might have other affected product throughout the hospital that was placing their patient at risk.This was now a patient safety issue and would like some kind of follow up from bd along with credit for all the kits that they were removing from inventory.Per customer follow up received on 17apr2024, it was reported that per initial complaint report, the exact allegation is that the foley catheter failed to drain the bladder.Per customer follow up received on 15may2024, customer returned another sample with material #119416m.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used foley catheter.Visual inspection of the sample noted the drainage lumen was flushed, and obstruction was immediately evidenced due to the drainage lumen being clogged, the solution would not come out through the eyelets due to the drainage lumen being clogged.The catheter shaft was cut in two pieces, evidencing that the obstruction was not in the funnel.Further inspection allowed to locate the drainage lumen completely clogged (0.2025'') from the last balloon ring.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿physiological obstruction¿.However, there was insufficient information to confirm this potential root cause.The reported event is addressed and the residual risk for this event is low.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "bard ez-lok sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip syringes 1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard ez-lok sampling port with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Directions for use proper techniques for urinary catheter insertion ¿ perform hand hygiene immediately before and after insertion ¿ insert urinary catheters using aseptic technique and sterile equipment ¿ use the smallest foley catheter possible, consistent with good drainage ¿ document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance ¿ secure the foley catheter, use the statlock foley stabilization device if provided ¿ maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions ¿ maintain unobstructed urine flow and keep the catheter and collection tube free from kinking ¿ keep the collection bag below the level of the bladder or hips at all times ¿ empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed foley catheter removal.Directions for use 1.Wash hands and don clean gloves 2.Explain procedure to patient and open peri-care kit 3.Use the provided packet of wipes to cleanse patient¿s peri urethral area 4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 5.Using proper aseptic technique open csr wrap 6.Don sterile gloves 7.Place under pad beneath patient, plastic/¿shiny¿ side down note: use caution to maintain aseptic technique 8.Position fenestrated drape on patient 9.Saturate 3 foam swab sticks in povidone iodine 10.Attach the water filled syringe to the inflation port note: it is not necessary to pre-test the foley catheter balloon 11.Remove foley catheter from wrap and lubricate catheter 12.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs 13.Proceed with catheterization in usual manner using the dominant hand a.When catheter tip has entered bladder, urine will be visible in the drainage tube b.Insert catheter two more inches and inflate catheter balloon 14.Inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe note: use of less than 10cc can result in asymmetrically inflated balloon 15.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck 16.Secure the foley catheter to the patient.Use the statlock foley stabilization device if provided (see statlock foley stabilization device ifu) 17.Position hanger on bed rail at the foot of the bed note: exercise care to keep bag off the floor 18.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked 19.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system 20.Document procedure according to hospital protocol note: use each swab stick for one swipe only female patient: with a downward stroke cleanse the right labia minora and discard the swab.Do the same for the left labia minora.With the last swab stick cleanse the middle area between the labia minora male patient: cleanse the penis in a circular motion starting at the urethral meatus and working outward foley catheter removal 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient" correction: b, d, f, h udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19104510
• Report Number: 1018233-2024-02060
• Device Sequence Number: 7840171
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148(11)231020(17)271130(10)NGHX1363
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 119416M
• Device Lot Number: NGHX1363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown